• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problems Migration or Expulsion of Device (1395); Infusion or Flow Problem (2964)
Patient Problems Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8709, lot# j10966r02, implanted: (b)(6) 2002, product type: catheter. Product id: 8578, serial# (b)(4), implanted: ((b)(6) 2011, product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 19-nov-2003, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2022, information was received from an healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving morphine (10 mg/ml, 0. 4494 mg/day) via an implantable pump for spinal pain. It was reported that the rep was attending a pump revision case on the date of the call. They patient had lost some weight so their pump had dropped down and was hitting on their bone. The revision was to move the existing pump from one side to the other. The hcp removed 3 cm from the pump segment and added 4 cm to the pump segment. The hcp was not able to aspirate however was not concerned about therapy. Therapy considerations were reviewed. The rep mentioned the surgeon had to take out some scar tissue out from the previous pocket.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14500508
MDR Text Key292981514
Report Number3004209178-2022-06771
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/25/2022 Patient Sequence Number: 1
-
-